Recall Z-1977-2019— CooperSurgical, Inc.
Class II · Terminated
Class II FDA medical device recall by CooperSurgical, Inc., initiated 2019-06-14, terminated 2020-05-19. It names one FDA 510(k) clearance: K180429. Product: Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm; Part No. AD750SC-KE25 The Advincula Delineator Uterine Manipulator is a single-use disposable device designed specifically for Total Laparoscopic Hysterectomy (TLH), Laparoscopic Assisted Vaginal Hysterectomy (LAVH), and/or Laparoscopic Supra-Cervical Hysterectomy (LSCH).. Reason: The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack when subjected to excessive compressions during use, leading to serious health consequences, such as lacerations..
- Recalling firm
- CooperSurgical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-06-14
- Terminated
- 2020-05-19
- Firm location
- Trumbull, CT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm; Part No. AD750SC-KE25 The Advincula Delineator Uterine Manipulator is a single-use disposable device designed specifically for Total Laparoscopic Hysterectomy (TLH), Laparoscopic Assisted Vaginal Hysterectomy (LAVH), and/or Laparoscopic Supra-Cervical Hysterectomy (LSCH).
Reason for recall
The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack when subjected to excessive compressions during use, leading to serious health consequences, such as lacerations.
Data sourced from openFDA. This site is unofficial and independent of the FDA.